study of visilizumab versus placebo in subjects with intravenous steroid-refractory ulcerative colitis previously responsive in a visilizumab study

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to compare the efficacy, safety, pharmacokinetics, and immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior visilizumab study.

the purpose of this study is to compare the efficacy, safety, pharmacokinetics, and immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior visilizumab study. pdl biopharma, inc. was formerly known as protein design labs, inc.

Eligibility criteria:
inclusion criteria: * males and females, 18 years of age or older. * only 1 prior treatment course with visilizumab (or placebo in a blinded visilizumab study). * response (as defined in parent protocol) of intravenous steroid-refractory ulcerative colitis (ivsr-uc) disease to visilizumab or placebo. * symptomatic worsening (ie, an increase of ≥3 points in mtwsi score) from the subject's best response on the parent study, an mtwsi score of ≥9, sustained for at least 2 assessments performed at least 1 week apart, and a confirmatory mtwsi ≥8 within 1 day prior to randomization. * cd4\^+ t-cell count ≥ 200 cells/mcl at screening for this protocol, or ≥ 80% of the subject's screening baseline count prior to enrollment on the parent study. * mayo assessment (including flexible sigmoidoscopy) performed by a trained, blinded evaluating physician within 2 weeks prior to randomization. * adequate contraception from the day of consent through 3 months after the last dose of study drug. * negative serum pregnancy test. * negative clostridium difficile test. * signed and dated informed consent, and health insurance portability and accountability act (hipaa) if applicable. exclusion criteria: * uc requiring immediate surgical, endoscopic, or radiologic interventions. * white blood cell count less than 2.5 x 10\^3/mcl; platelet count less than 150 x 10\^3/mcl; or hemoglobin less than 8 g/dl. * active, medically significant infections, particularly those of viral etiology, eg, known cytomegalovirus (cmv) colitis. this includes any incidence of opportunistic infections within the past 12 months. * live vaccination within 6 weeks prior to randomization. * significant organ dysfunction, including cardiac, renal, liver, cns, pulmonary, vascular, gastrointestinal, endocrine, or laboratory abnormality, history of myocardial infarction, coronary artery disease, congestive heart failure, or arrhythmias within 6 months prior to consent. * history of lymphoproliferative disorder (lpd) or malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix that has been adequately treated within the past five years. * seropositive for infection with human immunodeficiency virus (hiv-1), hepatitis b virus (hbv) surface antigen, or hepatitis c virus (hcv). * pregnancy or nursing. * treatment with any other uc salvage drugs (including but not limited to infliximab or another anti-tnf-a drug, cyclosporine, tacrolimus \[fk506\], adalimumab, thalidomide, or another experimental agent), or therapies (surgery, pheresis, affinity columns) since the first course of treatment with study drug in the parent visilizumab study. * treatment with any other investigational drug or therapy within 60 days prior to randomization. * nontherapeutic levels of chronic antiseizure medications in subjects with a history of seizures. * any condition that, in the investigator's opinion, makes the subject unsuitable for study participation.

Keywords: intravenous, steroid-refractory, ulcerative colitis